IL291556B2 - שיטות ותכשירים למתן של ארילסולפטאז a למערכת העצבים המרכזית - Google Patents
שיטות ותכשירים למתן של ארילסולפטאז a למערכת העצבים המרכזיתInfo
- Publication number
- IL291556B2 IL291556B2 IL291556A IL29155622A IL291556B2 IL 291556 B2 IL291556 B2 IL 291556B2 IL 291556 A IL291556 A IL 291556A IL 29155622 A IL29155622 A IL 29155622A IL 291556 B2 IL291556 B2 IL 291556B2
- Authority
- IL
- Israel
- Prior art keywords
- formulation
- approximately
- polysorbate
- concentration
- following
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 55
- 102100022146 Arylsulfatase A Human genes 0.000 title claims 13
- 108010036867 Cerebroside-Sulfatase Proteins 0.000 title claims 13
- 238000009472 formulation Methods 0.000 claims 52
- 229920000136 polysorbate Polymers 0.000 claims 9
- 229950008882 polysorbate Drugs 0.000 claims 9
- 229910019142 PO4 Inorganic materials 0.000 claims 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 6
- 239000010452 phosphate Substances 0.000 claims 6
- 239000004094 surface-active agent Substances 0.000 claims 6
- 229920001213 Polysorbate 20 Polymers 0.000 claims 4
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 4
- 229940068977 polysorbate 20 Drugs 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 102000004169 proteins and genes Human genes 0.000 claims 3
- 108090000623 proteins and genes Proteins 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 201000011442 Metachromatic leukodystrophy Diseases 0.000 claims 2
- 229920001219 Polysorbate 40 Polymers 0.000 claims 2
- 229920001214 Polysorbate 60 Polymers 0.000 claims 2
- 108091006629 SLC13A2 Proteins 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 239000005388 borosilicate glass Substances 0.000 claims 2
- 238000007913 intrathecal administration Methods 0.000 claims 2
- 238000001990 intravenous administration Methods 0.000 claims 2
- 238000007914 intraventricular administration Methods 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 claims 2
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 claims 2
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 claims 2
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 claims 2
- 229920001296 polysiloxane Polymers 0.000 claims 2
- 229940101027 polysorbate 40 Drugs 0.000 claims 2
- 229940113124 polysorbate 60 Drugs 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 239000003708 ampul Substances 0.000 claims 1
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 210000005260 human cell Anatomy 0.000 claims 1
- 230000001506 immunosuppresive effect Effects 0.000 claims 1
- 238000002650 immunosuppressive therapy Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000012669 liquid formulation Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000088 plastic resin Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 229940071643 prefilled syringe Drugs 0.000 claims 1
- 239000004447 silicone coating Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0085—Brain, e.g. brain implants; Spinal cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y301/00—Hydrolases acting on ester bonds (3.1)
- C12Y301/06—Sulfuric ester hydrolases (3.1.6)
- C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Psychology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Genetics & Genomics (AREA)
- General Engineering & Computer Science (AREA)
- Psychiatry (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- Hospice & Palliative Care (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (8)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US35885710P | 2010-06-25 | 2010-06-25 | |
| US36078610P | 2010-07-01 | 2010-07-01 | |
| US38786210P | 2010-09-29 | 2010-09-29 | |
| US201161435710P | 2011-01-24 | 2011-01-24 | |
| US201161442115P | 2011-02-11 | 2011-02-11 | |
| US201161476210P | 2011-04-15 | 2011-04-15 | |
| US201161495268P | 2011-06-09 | 2011-06-09 | |
| PCT/US2011/041926 WO2011163650A2 (en) | 2010-06-25 | 2011-06-25 | Methods and compositions for cns delivery of arylsulfatase a |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| IL291556A IL291556A (he) | 2022-05-01 |
| IL291556B1 IL291556B1 (he) | 2023-10-01 |
| IL291556B2 true IL291556B2 (he) | 2024-02-01 |
Family
ID=46888844
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IL291556A IL291556B2 (he) | 2010-06-25 | 2011-06-25 | שיטות ותכשירים למתן של ארילסולפטאז a למערכת העצבים המרכזית |
| IL223758A IL223758B (he) | 2010-06-25 | 2012-12-20 | שיטות ותכשירים למתן של ארילסולפטאז a למערכת העצבים המרכזית |
| IL273854A IL273854B (he) | 2010-06-25 | 2020-04-06 | שיטות ותכשירים למתן של ארילסולפטאז a למערכת העצבים המרכזית |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IL223758A IL223758B (he) | 2010-06-25 | 2012-12-20 | שיטות ותכשירים למתן של ארילסולפטאז a למערכת העצבים המרכזית |
| IL273854A IL273854B (he) | 2010-06-25 | 2020-04-06 | שיטות ותכשירים למתן של ארילסולפטאז a למערכת העצבים המרכזית |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US9770410B2 (he) |
| EP (3) | EP3626257B1 (he) |
| JP (1) | JP6045493B2 (he) |
| KR (4) | KR102094094B1 (he) |
| CN (1) | CN103282046B (he) |
| AU (4) | AU2011270670B2 (he) |
| BR (1) | BR112012033216B1 (he) |
| CA (1) | CA2803003C (he) |
| CY (2) | CY1122282T1 (he) |
| DK (1) | DK2585104T3 (he) |
| ES (1) | ES2754776T3 (he) |
| HR (1) | HRP20191923T1 (he) |
| IL (3) | IL291556B2 (he) |
| LT (1) | LT2585104T (he) |
| ME (1) | ME03647B (he) |
| MX (1) | MX344795B (he) |
| NZ (2) | NZ605873A (he) |
| PL (2) | PL3626257T3 (he) |
| RS (1) | RS59468B1 (he) |
| RU (1) | RU2671503C2 (he) |
| SI (1) | SI2585104T1 (he) |
| TW (1) | TWI667037B (he) |
| UA (1) | UA115650C2 (he) |
| WO (1) | WO2011163650A2 (he) |
| ZA (1) | ZA201300675B (he) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20180130A1 (es) | 2010-06-25 | 2018-01-18 | Shire Human Genetic Therapies | Composiciones y metodos para suministro al sistema nervioso central de arilsulfatasa a |
| US8545837B2 (en) | 2010-06-25 | 2013-10-01 | Shire Human Genetic Therapies, Inc. | Methods and compositions for CNS delivery of iduronate-2-sulfatase |
| UA115650C2 (uk) | 2010-06-25 | 2017-12-11 | Шае Хюмен Дженетік Терапіс, Інк. | Способи та композиції для доставки до цнс арилсульфатази а |
| PE20230169A1 (es) | 2010-06-25 | 2023-02-01 | Shire Human Genetic Therapies | Suministro al sistema nervioso central de agentes terapeuticos |
| RU2012154576A (ru) | 2010-06-25 | 2014-07-27 | Шир Хьюман Дженетик Терапис, Инк. | Способы и композиции для доставки к цнс гепаран-n-сульфатазы |
| WO2013096899A2 (en) | 2011-12-23 | 2013-06-27 | Shire Human Genetic Therapies, Inc. | Stable formulations for cns delivery of arylsulfatase a |
| MX2015008875A (es) * | 2013-01-09 | 2015-10-22 | Shire Human Genetic Therapies | Metodos para la purificacion de arilsulfatasa a. |
| BR112015028605A8 (pt) * | 2013-05-15 | 2019-12-24 | Univ Minnesota | uso de uma composição e uso de um imunossupressor e uma composição |
| US10208734B2 (en) * | 2015-04-23 | 2019-02-19 | Continuum Dynamics, Inc. | Lift-driven wind turbine with force canceling blade configuration |
| ES2866050T3 (es) * | 2015-07-10 | 2021-10-19 | Byondis Bv | Composiciones que comprenden conjugados de anticuerpos-fármaco duocarmicina |
| AU2017220100B2 (en) | 2016-02-17 | 2024-04-04 | Takeda Pharmaceutical Company Limited | Methods and compositions for CNS delivery of arylsulfatase A |
| HUE057856T2 (hu) * | 2016-06-01 | 2022-06-28 | Servier Ip Uk Ltd | Polialkilén-oxid-aszparagináz készítményei és eljárás ezek elõállítására és alkalmazására |
| BR112019013202A2 (pt) * | 2016-12-28 | 2019-12-10 | Japan Chem Res | formulação liofilizada |
| AU2018335752A1 (en) | 2017-09-22 | 2020-03-12 | Christian HINDERER | Gene therapy for treating Mucopolysaccharidosis type ii |
| AU2018393045A1 (en) | 2017-12-19 | 2020-07-02 | Takeda Pharmaceutical Company Limited | Purified arylsulfatase A and compositons thereof |
| WO2020004368A1 (ja) * | 2018-06-25 | 2020-01-02 | Ｊｃｒファーマ株式会社 | 蛋白質含有水性液剤 |
| WO2021061517A1 (en) * | 2019-09-23 | 2021-04-01 | University Of Washington | Assay of arylsulfatase a enzymatic activity in dried blood spots by mass spectrometry and fluorometry |
| WO2024176112A1 (en) | 2023-02-21 | 2024-08-29 | Takeda Pharmaceutical Company Limited | Large scale production of recombinant arylsulfatase a and compositions thereof |
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| US5863782A (en) | 1995-04-19 | 1999-01-26 | Women's And Children's Hospital | Synthetic mammalian sulphamidase and genetic sequences encoding same |
| US6118045A (en) * | 1995-08-02 | 2000-09-12 | Pharming B.V. | Lysosomal proteins produced in the milk of transgenic animals |
| DK0900569T3 (da) | 1997-08-22 | 2003-01-27 | Seikagaku Kogyo Co Ltd | Terapeutisk middel til behandling af herniaramt intervertebral diskus |
| CA2353522A1 (en) | 1998-12-07 | 2000-06-15 | Pharming Intellectual Property B.V. | Treatment of pompe's disease |
| US6217552B1 (en) | 1999-03-01 | 2001-04-17 | Coaxia, Inc. | Medical device for selective intrathecal spinal cooling in aortic surgery and spinal trauma |
| US20020052311A1 (en) | 1999-09-03 | 2002-05-02 | Beka Solomon | Methods and compostions for the treatment and/or diagnosis of neurological diseases and disorders |
| US6642038B1 (en) | 1999-09-14 | 2003-11-04 | Genzyme Glycobiology Research Institute, Inc. | GlcNAc phosphotransferase of the lysosomal targeting pathway |
| US20020099025A1 (en) | 1999-12-30 | 2002-07-25 | Heywood James A. | Treatment of neurological disorders |
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